Diagnostic yield of Franseen and Fork-Tip biopsy needles for endoscopic ultrasound-guided tissue acquisition: a meta-analysis

Background and study aims Although newer needle designs are thought to improve diagnostic outcomes of endoscopic ultrasound-guided fine-needle biopsy, there is limited evidence on their diagnostic performance. The aim of this meta-analysis was to provide a pooled estimate of the diagnostic performance and safety profile of Franseen and Fork-tip fine-needle biopsy needles. Patients and methods Computerized bibliographic search on the main databases was performed through March 2019. The primary endpoint was sample adequacy. Secondary outcomes were diagnostic accuracy, optimal histological core procurement, mean number of needle passes, pooled specificity and sensitivity. Safety data were also analyzed. Results Twenty-four studies with 6641 patients were included and pancreas was the prevalent location of sampled lesions. Overall sample adequacy with the two newer needles was 94.8 % (93.1 % – 96.4 %), with superiority of Franseen needle over Fork-tip (96.1 % versus 92.4 %, P < 0.001). Sample adequacy in targeting pancreatic masses was 95.6% and both needles produced results superior to fine-needle aspiration (FNA) (odds ratio 4.29, 1.49 – 12.35 and 1.79, 1.01 – 3.19 with Franseen and Fork-tip needle, respectively). The rate of histological core procurement was 92.5%, whereas diagnostic accuracy and sensitivity were 95 % and 92.8 %, again with no difference between the two needles. Number of needle passes was significantly lower in comparison to FNA (mean difference: –0.42 with Franseen and –1.60 with Fork-tip needle). No significant adverse events were registered. Conclusion Our meta-analysis speaks in favor of use of newer biopsy needles as a safe and effective tool in endoscopic ultrasound-guided tissue acquisition.